Prior
to the trial of this matter, I heard oral argument on various
motions in limine filed by the Parties. At the
hearing, I denied Ethicon's Motion to Admit FDA Evidence,
DE 248, and granted and the Kaisers' mirror image motion
to exclude FDA evidence, DE 244. I provided a detailed
explanation from the bench on the reasons for those rulings,
but I also told the Parties that a written opinion would
follow. [DE 276 at 34-40.] This is that opinion.

While
this case was before him as part of the MDL, Judge Goodwin
excluded evidence regarding the FDA's §510(k)
clearance process. [See, e.g., DE 146.] Judge
Goodwin explained:

I have repeatedly excluded evidence regarding the FDA's
section 510(k) clearance process in these MDLs, and will
continue to do so in these case[sic], a position that has
been affirmed by the Fourth Circuit. In re C. R. Bard,
Inc., 81 F.3d 913, 921-23 (4th Cir. 2016) (upholding the
determination that the probative value of evidence related to
section 510(k) was substantially outweighed by its possible
prejudicial impact under Rule 403). Because the section
510(k) clearance process does not speak directly to safety
and efficacy, it is of negligible probative value. See In
re C. R. Bard, 81 F.3d at 920 (“[T]he clear weight
of persuasive and controlling authority favors a finding that
the 510(k) procedure is of little or no evidentiary
value.”). Delving into complex and lengthy testimony
about regulatory compliance could inflate the perceived
importance of compliance and lead jurors “to
erroneously conclude that regulatory compliance proved
safety.” Id. at 922. Accordingly, expert
testimony related to the section 510(k) process, including
subsequent enforcement actions and discussion of the
information Ethicon did or did not submit in its section
510(k) application, is EXCLUDED.

[Id.]

The
issue of the admissibility of FDA §510(k) evidence was
reanimated before me because the Indiana Product Liability
Act provides a rebuttable presumption that a product is not
defective, and the manufacturer is not negligent, where the
product complied with applicable codes, standards,
regulations, or specification. See Ind. Code §
34-20-5-1. Ethicon argues that evidence regarding the fact
that Prolift was cleared for marketing through §501(k)
review was relevant to this litigation because of the
IPLA's rebuttable presumption and, in fact, mandated
application of the presumption to this case.

Before
I explain why I agree with Judge Goodwin, and the majority of
the other courts that have addressed this issue, some
background on the §510(k) process is necessary. The
§510(k) review process originates from the Medical
Device Amendments of 1976 (MDA) to the Federal Food, Drug,
and Cosmetic Act. The MDA was enacted in order to
“impose[ ] a regime of detailed federal
oversight” of medical devices. Riegel v. Medtronic,
Inc., 552 U.S. 312, 316 (2008). Under the MDA, certain
devices must complete a thorough premarket approval (PMA)
process with the FDA before they may be marketed, including
all devices that cannot “provide reasonable assurance
of [their] safety and effectiveness” under less
stringent scrutiny, and that are “purported or
represented to be for a use in supporting or sustaining human
life or for a use which is of substantial importance in
preventing impairment of human health” or
“present[ ] a potential unreasonable risk of illness or
injury.” Id. at 317; 21 U.S.C. §
360c(a)(1)(C). The PMA process requires the applicant to
demonstrate a “reasonable assurance” that the
device is both “safe and effective under the conditions
of use prescribed, recommended, or suggested in the proposed
labeling thereof.” Buckman Co. v. Plaintiffs'
Legal Comm., 531 U.S. 341, 344 (2001) (quoting 21 U.S.C.
§ 360e(d)(2)(A), (B)).

However,
an exception to the PMA requirement exists for medical
devices that were already on the market prior to the
MDA's enactment in 1976; these devices are allowed to
remain on the market until the FDA initiates and completes
PMA review for them. See 21 U.S.C. §
360e(b)(1)(A); Buckman, 531 U.S. at 345. In
addition, to prevent the monopolistic power that this
exception might bestow on the manufacturer of the predicate
device, the MDA also allows other manufacturers to piggyback
on earlier products by allowing them to market devices that
are shown to be “substantially equivalent” to
pre-1976 devices that are exempt from the PMA requirement.
Buckman, 531 U.S. at 345; 21 U.S.C. §
360e(b)(1)(B)). The §510(k) process is the method by
which a manufacturer demonstrates substantial equivalence.
Id.

While
the MDA provided this initial framework, the Safe Medical
Devices Act of 1990 provided firmer footing for this loosely
designed process. The SMDA finally codified the definition of
substantial equivalence that the FDA had developed
administratively through the experience of clearing devices
for the 14 years since the enactment of the MDA. See
21 U.S.C. §360c(i). In addition, the SMDA ended the
legal necessity to cite a pre-MDA predicate device, so that
devices cleared after the enactment of the MDA could be used
as predicates without construction of a clearance chain back
to a pre-MDA predicate device. See 21 U.S.C.
§360c(f). While this allowed the state of the art to
evolve more freely, it created a more tangential relationship
between FDA clearance and the safety-focused PMA process.

Returning
to the case at hand, in September 2007, Ethicon submitted its
§510(k) notice to the FDA for Prolift. [DE 248-4.] The
FDA found Prolift “substantially equivalent . . . to
legally marketed predicated devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the
Medical Device Amendments, or to devices that have been
reclassified in accordance with the provisions of the Federal
Food, Drug, and Cosmetic Act that do not require approval of
a premarket approval application, ” classifying Prolift
as a Class II device and clearing it to proceed to market in
May 2008. [DE 248-5.] The notice explicitly stated that
“FDA's issuance of a substantial equivalence
determination does not mean that FDA has made a determination
that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other
Federal agencies.” [Id.]

Ethicon
argues that evidence of this clearance is relevant to this
action because it entitles Ethicon to the rebuttable
presumption found in Ind. Code § 34-20-5-1. I disagree.
Indiana Code § 34-20-5-1 provides:

In a product liability action, there is a rebuttable
presumption that the product that caused the physical harm
was not defective and that the manufacturer or seller of the
product was not negligent if, before the sale by the
manufacturer, the product:

(1) was in conformity with the generally recognized state of
the art applicable to the safety of the product at the time
the product was designed, manufactured, packaged, and
labeled; or

(2) complied with applicable codes, standards, regulations,
or specifications established, adopted, promulgated, or
approved by the United States or by Indiana, or by an ...

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